Adherence to Antiretroviral Prophylaxis for HIV Prevention: A Substudy Cohort within a Clinical Trial of Serodiscordant Couples in East Africa

作者：Haberer Jessica E^*; Baeten Jared M; Campbell James; Wangisi Jonathan; Katabira Elly; Ronald Allan; Tumwesigye Elioda; Psaros Christina; Safren Steven A; Ware Norma C; Thomas Katherine K; Donnell Deborah; Krows Meighan; Kidoguchi Lara; Celum Connie; Bang**erg David R

来源：PLOS MEDICINE, 2013, 10(9): e1001511.

DOI：10.1371/journal.pmed.1001511

Background: Randomized clinical trials of oral antiretroviral pre-exposure prophylaxis (PrEP) for HIV prevention have widely divergent efficacy estimates, ranging from 0% to 75%. These discrepancies are likely due to differences in adherence. To our knowledge, no studies to date have examined the impact of improving adherence through monitoring and/or intervention, which may increase PrEP efficacy, or reported on objective behavioral measures of adherence, which can inform PrEP effectiveness and implementation. %26lt;br%26gt;Methods and Findings: Within the Partners PrEP Study (a randomized placebo-controlled trial of oral tenofovir and emtricitabine/tenofovir among HIV-uninfected members of serodiscordant couples in Kenya and Uganda), we collected objective measures of PrEP adherence using unannounced home-based pill counts and electronic pill bottle monitoring. Participants received individual and couples-based adherence counseling at PrEP initiation and throughout the study; counseling was intensified if unannounced pill count adherence fell to %26lt;80%. Participants were followed monthly to provide study medication, adherence counseling, and HIV testing. A total of 1,147 HIV-uninfected participants were enrolled: 53% were male, median age was 34 years, and median partnership duration was 8.5 years. Fourteen HIV infections occurred among adherence study participants-all of whom were assigned to placebo (PrEP efficacy = 100%, 95% confidence interval 83.7%-100%, p%26lt; 0.001). Median adherence was 99.1% (interquartile range [IQR] 96.9%-100%) by unannounced pill counts and 97.2% (90.6%-100%) by electronic monitoring over 807 person-years. Report of no sex or sex with another person besides the study partner, younger age, and heavy alcohol use were associated with %26lt;80% adherence; the first 6 months of PrEP use and polygamous marriage were associated with %26gt;80% adherence. Study limitations include potential shortcomings of the adherence measures and use of a convenience sample within the substudy cohort. %26lt;br%26gt;Conclusions: The high PrEP adherence achieved in the setting of active adherence monitoring and counseling support was associated with a high degree of protection from HIV acquisition by the HIV-uninfected partner in heterosexual serodiscordant couples. Low PrEP adherence was associated with sexual behavior, alcohol use, younger age, and length of PrEP use.

• 出版日期2013-9